Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device descriptions and performance studies focus on chemical and biological indicators that change color or exhibit fluorescence based on exposure to hydrogen peroxide, which are physical/chemical reactions, not AI/ML processes. The mention of "ALLClear™ Technology" and the "STERRAD VELOCITY™ Reader" with a specific software version do not inherently indicate AI/ML; they likely refer to automated system checks or data processing, not learning algorithms. There is no mention of AI, ML, or related concepts in the text.

Therapeutic

No.
The device described is a chemical indicator, biological indicator, or tape used to monitor sterilization processes, not to treat or diagnose patients.

Diagnostic

No

The device is a process indicator (or biological indicator/process challenge device) used to verify that sterilization processes have occurred, not to diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like chemically reactive ink, styrene strips, tape, and vials. While a reader device is mentioned (which likely contains software), the core devices being described (chemical indicators, biological indicators, and PCDs) are physical objects.

IVD (In Vitro Diagnostic)

Based on the provided information, these devices are not In Vitro Diagnostics (IVDs).

Here's why:

Intended Use: The intended use of all the described devices is to monitor the effectiveness of sterilization processes for medical devices. They are used with medical devices that will be used on patients, but they themselves are not used to diagnose, treat, or prevent disease in a patient by examining specimens derived from the human body.
Device Description: The descriptions detail chemical indicators and biological indicators that react to the sterilization process (hydrogen peroxide). They do not describe devices that analyze biological samples.
Anatomical Site and Patient Age Range: These are listed as "Not Applicable," which is consistent with devices that are not used directly on or with a patient's biological material.
Performance Studies: The performance studies focus on the functionality of the indicators in response to the sterilization process (color change, growth inhibition, fluorescence), not on the analysis of biological specimens.

In summary, these devices are sterilization process indicators, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The STERRAD™ Chemical Indicator (CI) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:

-STERRAD™ 100S Sterilization System
-STERRAD NXTM Sterilization System
oSTANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
-STERRAD™ 100NX Sterilization System
oSTANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology
oULTRA GITM Cycle with Integrated ALLClear Technology

STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:

-STERRAD™ 100S Sterilization System
-STERRAD NXTM Sterilization System
oSTANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
-STERRAD™ 100NX Sterilization System
oSTANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
oULTRA GITM Cycle with Integrated ALLClear™ Technology
The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed loads.

The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:

-STERRAD™ 100NX Sterilization System
oSTANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
oULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only).
-STERRAD NXTM Sterilization System
o(STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
-STERRAD™ 100S Sterilization System

The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (BI) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ 100NX Sterilization System with ALLClear™ Technology.

Product codes (comma separated list FDA assigned to the subject device)

JOJ, FRC

Device Description

The STERRAD™ Chemical Indicator (Cl) Strip consists of chemically reactive ink, a clear overcoat ink, a yellow comparator bar, and black ink for copy printed on a strip of white styrene. This device is a through-put process indicator to be used with ASP's STERRAD™ Sterilization Systems. The STERRAD Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. When in the presence of hydrogen peroxide, the indicator will change from red to yellow as indicated by the comparator bar to indicate that the load has been exposed to hydrogen peroxide.

The STERRAD Chemical Indicator (CI) Strip does not imply that sterilization has been achieved or to assure that the sterilization cycle has been completed. Rather, it provides a visual indication that hydrogen peroxide, an essential ingredient in the operation of the STERRAD System sterilization process, is present in the sterilization chamber.

The STERRAD™ SEALSURE™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD™ Sterilization Systems that utilize hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices.

The Chemical Indicator Tape reacts with hydrogen peroxide as it is introduced into the sterilization chamber. The chemical reaction between the indicator ink and the hydrogen peroxide causes the dye of the indicator ink on the diagonal STERRAD logos and the chemical indicator square on the tape to change color, indicating that the load has been exposed to hydrogen peroxide.

STERRAD SEALSURE Chemical Indicator Tape does not imply that sterilization has been achieved or to assure that the sterilization cycle has been completed.

The STERRAD VELOCITY Biological Indicator (BI) is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and/or periodic testing in STERRAD Sterilization Systems.

The assembled ULTRA GI PCD is composed of a vial that encapsulates the STERRAD VELOCITY Biological Indicator (BI). The vial creates a stronger resistance to the ULTRA GI Cycle. At the end of the Bl is removed from the vial and used in conjunction with the STERRAD VELOCITY Reader (software version 1139260417 or newer) to verify the effectiveness of the ULTRA GI PCD Vial is only used for the ULTRA GI Cycle in STERRAD 100NX Sterilizers.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care providers

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Chemical Indicator Functionality

This study verified the Chemical Indicator functionality after processing in the ULTRA GI Cycle.
Acceptance Criteria: The Chemical Indicator will not change color when not exposed to the cycle parameter indication. The Chemical Indicator will change color when exposed to cycle parameter indication.
Result: Pass

Residual Biocompatibility

This study demonstrated the biocompatibility of the Chemical Indicator post processing in the ULTRA GI Cycle.
Acceptance Criteria: The residual hydrogen peroxide level shall be below the LOQ and exhibit mild toxicity or lower.
Result: Pass

End Point /Post Processing Color Stability

This study demonstrated that the Chemical Indicator will perform to the Type 1 requirements of ISO 11140-1:2014.
Acceptance Criteria: The chemical indicator shall perform to the Type 1 requirements of ISO 11140-1:2014.
Result: Pass

Tape Adhesion Strength

This study verifies the adhesive strength after processing in the ULTRA GI Cycle.
Acceptance Criteria: The peel strength (adhesion-strength) must meet the acceptance criteria.
Result: Pass

Biological Indicator Performance

This study verified the use of the Biological Indicator for use in frequent monitoring of the ULTRA GI Cycle.
Acceptance Criteria: General trend of increasing number of sterile BIs (growth and fluorescence) with increasing hydrogen peroxide injection volume. All BIs negative for fluorescence and growth at full cycle.
Result: Pass

Verification of Growth Inhibition of the Biological Indicator

The study demonstrated that there is no inhibition effect on the STERRAD VELOCITY BI carrier and primary packaging materials processed through the ULTRA GI Cycle.
Acceptance Criteria: All test samples (positive controls) show growth. All negative controls show no growth.
Result: Pass

Chemical Indicator Functionality of Biological Indicator

This study verified the Chemical Indicator functionality after processing in the ULTRA GI Cycle.
Acceptance Criteria: Chemical Indicator will not change color when not exposed to the cycle parameter indication. Chemical Indicator will change color when exposed to cycle parameter indication.
Result: Pass

Fluorescence Performance of Biological Indicator

This study verified the accuracy of the Fluorescence results compared to growth positive BIs.
Acceptance Criteria: BI fluorescence-positive for greater than 97.0% of all growth-positive BIs.
Result: Pass

Hydrogen Peroxide Dose-Response and Sterilization Verification

This study verified the design of the ULTRA GI PCD fluorescence. The BI readout in conjunction with the PCD vial provides a greater resistance in comparison to the biological model to the sterilization process using the ULTRA GI Cycle.
Acceptance Criteria: The general trend is an increasing number of sterile BIs (growth and fluorescence) with increasing hydrogen peroxide injection volume. All BIs are negative for fluorescence and growth at full cycle.
Result: Pass

Performance Qualification

This study verified the fluorescence read performance when used for period testing and frequent monitoring.
Acceptance Criteria: The STERRAD VELOCITY BI/PCD fluorescence readout is qualified for performance in frequent monitoring and periodic testing indication.
Result: Pass

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111518, K111519, K192025

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

July 5, 2024

Advanced Sterilization Products, Inc. Brandon Roberts Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618

Re: K234084

Trade/Device Name: STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (60 count) (43210); STERRAD VELOCITY™ Biological Indicator (BI) (30 count) (43210-30): STERRAD VELOCITY™ Reader (43220): ULTRA GITM Process Challenge Device (PCD) Vial (30 count) (43400) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ, FRC Dated: December 22, 2023 Received: June 7, 2024

Dear Brandon Roberts:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

2

Sincerely, Christopher K. Dugard -2

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

510(k) Number (if known) K234084

Device Name

STERRAD™ Chemical Indicator (CI) Strip (14100)

Indications for Use (Describe)

The STERRAD™ Chemical Indicator (CI) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:

· STERRAD™ 100S Sterilization System
· STERRAD NXTM Sterilization System

o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology

· STERRAD™ 100NX Sterilization System
- o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GITM Cycle with Integrated ALLClear Technology

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

4

510(k) Number (if known) K234084

Device Name

STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape (14202NL)

Indications for Use (Describe)

STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:

· STERRAD™ 100S Sterilization System

· STERRAD NXTM Sterilization System

o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology

· STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear™ Technology

The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed loads.

Type of Use (Select one or both, as applicable)

Residential Use (Per 24 CFR 982.305) Primary Residence	Rent To Owner (Per 24 CFR 982.305) Primary Residence
---------------------------------------------------------------------------------	------------------------------------------------------------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

5

510(k) Number (if known) K234084

Device Name

STERRAD VELOCITY™ Biological Indicator (BI) (60 count) (43210); STERRAD VELOCITY™ Biological Indicator (BI) (30 count) (43210-30); STERRAD VELOCITY™ Reader (43220)

Indications for Use (Describe)

The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:

· STERRAD™ 100NX Sterilization System

o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology

o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only).

· STERRAD NXTM Sterilization System
o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology

· STERRAD™ 100S Sterilization System

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

6

510(k) Number (if known) K234084

Device Name

ULTRA GITM Process Challenge Device (PCD) Vial (43400) (30 count)

Indications for Use (Describe)

The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (BI) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ 100NX Sterilization System with ALLClear™ Technology.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

7

510(k) Summary for K234084 Advanced Sterilization Products, Inc. STERRAD™ Chemical Indicator (CI) Strip

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information

Submitter Name:	Advanced Sterilization Products, Inc.
Address:	33 Technology Drive
	Irvine, CA 92618
Contact Person:	Brandon Roberts
	Senior Regulatory Affairs Specialist
	Phone: (323) 590-4214
	Email: brandon.roberts@asp.com
Date Prepared:	July 2, 2024
Device Name
Proprietary Name:	STERRAD™ Chemical Indicator (CI) Strip (14100)
Common Name:	Chemical Sterilization Process Indicator Strip
Classification Name:	Indicator, Physical/Chemical Sterilization Process
Device Class:	Class II
Product Code:	JOJ
CFR Section:	21 CFR 880.2800

Predicate Device

STERRAD® Chemical Indicator Strip cleared under 510(k) K111518 on October 3, 2012.

8

Device Description

The STERRAD™ Chemical Indicator (Cl) Strip consists of chemically reactive ink, a clear overcoat ink, a yellow comparator bar, and black ink for copy printed on a strip of white styrene. This device is a through-put process indicator to be used with ASP's STERRAD™ Sterilization Systems. The STERRAD Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. When in the presence of hydrogen peroxide, the indicator will change from red to yellow as indicated by the comparator bar to indicate that the load has been exposed to hydrogen peroxide.

The STERRAD Chemical Indicator (CI) Strip does not imply that sterilization has been achieved or to assure that the sterilization cycle has been completed. Rather, it provides a visual indication that hydrogen peroxide, an essential ingredient in the operation of the STERRAD System sterilization process, is present in the sterilization chamber.

Intended Use/Indications For Use

The STERRAD™ Chemical Indicator (Cl) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:

. STERRAD™ 100S Sterilization System
. STERRAD NX™ Sterilization System
- STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology o
. STERRAD™ 100NX Sterilization System
- o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology
- ULTRA GI™ Cycle with Integrated ALLClear Technology o

Device Characteristics	Subject Device	Predicate Device
	STERRAD™ Chemical Indicator
Strip (K234084)	STERRAD® Chemical Indicator
Strip (K111518)
Intended Use	The STERRAD™ Chemical
Indicator (CI) Strip is a process
indicator that is intended to
differentiate processed from
unprocessed packages and is
intended for use with medical
device packages to be
sterilized in STERRAD™
Sterilization Systems.	Same
Indications for Use	The STERRAD™ Chemical
Indicator (CI) Strip is a process
indicator per ISO 11140-1:2014
[Type ] (to differentiate
processed from unprocessed	The STERRAD® Chemical
Indicator Strip (PN 14100) is a
process indicator (ISO 11140-
1:2005) to differentiate
processed from unprocessed

Comparison of Technological Characteristics

9

Device Characteristics	Subject Device	Predicate Device
	STERRAD™ Chemical Indicator
Strip (K234084)
packages) and is intended for
use with medical device
packages to be sterilized in the
following STERRAD™
Sterilization Systems:
STERRAD™ 100S
Sterilization System STERRAD NX™
Sterilization System STANDARD AND
ADVANCED
Cycles with and
without
ALLClear™
Technology STERRAD™ 100NX
Sterilization System STANDARD,
FLEX, EXPRESS,
and DUO Cycles
with and
without
ALLClear
Technology ULTRA GI™
Cycle with
Integrated
ALLClear
Technology	STERRAD® Chemical Indicator
Strip (K111518)
packages and is intended for
use with medical device
packages to be sterilized in
STERRAD® Sterilization
Systems:
MODEL CYCLE STERRAD®
100S Standard STERRAD®
50 Standard STERRAD®
200 Standard STERRAD®
NX® Standard
Advanced STERRAD®
100NX® Standard
Flex
Express
DUO
Contraindications	None	Same
Precautions	1. Do not use after the
expiration date.

STERRAD CI Strip is not
indicated for use with
steam or ethylene oxide
sterilization cycles.
If the indicator bar has
not completely changed
from red to yellow (or
lighter) indicated by the
comparator bar, | Same | | | | | | | | | | | | |

10

Device Characteristics	Subject Device	Predicate Device
	STERRAD™ Chemical Indicator
Strip (K234084)	STERRAD® Chemical Indicator
Strip (K111518)
	introduction of hydrogen
peroxide, an essential
component of the
STERRAD Sterilization
Cycle, may not have
taken place.

Single use only. Do not
reuse as the Chemical
Indicator Strip will not
function as intended if
reused. | |
| Regulation/Product Code | 880.2800 /JOJ | Same |
| Technology | Through-put process indicator | Same |
| Device Design: Functionality | Strip with Chemical Indicator | Same |
| Device Design: Chemical
Reaction | N-Oxidation of tertiary amine in
the presence of hydrogen
peroxide. | Same |
| Device Design: Cycle Parameter
Indication | Hydrogen Peroxide | Same |
| Device Design | Indicator bar changes from red
to yellow (or lighter) as
indicated by comparator bar
when exposed to
hydrogen peroxide. | Same |
| Distinct Color Change | Red (pre-processed) to yellow
or lighter (post-processed) as
indicated by comparator bar. | Same |
| Endpoint Color | Yellow or lighter as indicated
by comparator bar (Pantone
Color Formula Guide 144C). | Same |
| Single Use | Yes | Same |
| Over the Counter Use Device | Yes | Same |
| Packaging | Four cartons per shipper box
with each carton consisted of
250 strips placed in a
polyethylene bag. | Same |

11

Performance Testing	Description	Acceptance Criteria	Pass/Fail
Chemical Indicator
Functionality	This study verified the
Chemical Indicator
functionality after
processing in the ULTRA
GI Cycle.	The Chemical Indicator
will not change color
when not exposed to
the cycle parameter
indication.
The Chemical Indicator
will change color when
exposed to cycle
parameter indication.	Pass
Residual
Biocompatibility	This study
demonstrated the
biocompatibility of the
Chemical Indicator post
processing in the ULTRA
GI Cycle.	The residual hydrogen
peroxide level shall be
below the LOQ and
exhibit mild toxicity or
lower.	Pass
End Point /Post
Processing Color
Stability	This study
demonstrated that the
Chemical Indicator will
perform to the Type 1
requirements of ISO
11140-1:2014.	The chemical indicator
shall perform to the
Type 1 requirements of
ISO 11140-1:2014.	Pass

Summary of Non-Clinical Testing

Summary

The subject device, STERRAD Chemical Indicator (CI) Strip (14100), and its predicate utilize the same technology and verification/validation methods to achieve its intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject device to be as safe and effective as the predicate.

Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the existing legally marketed predicate device, K111518.

12

510(k) Summary for K234084 Advanced Sterilization Products, Inc. STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information

Submitter Name:	Advanced Sterilization Products, Inc.
Address:	33 Technology Drive
Irvine, CA 92618
Contact Person:	Brandon Roberts
Senior Regulatory Affairs Specialist
Phone: (323) 590-4214
Email: brandon.roberts@asp.com
Date Prepared:	July 2, 2024
Device Name
Proprietary Name:	STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape
(14202NL)
Common Name:	Chemical Sterilization Process Indicator Tape
Classification Name:	Indicator, Physical/Chemical Sterilization Process
Device Class:	Class II
Product Code:	JOJ
CFR Section:	21 CFR 880.2800

Predicate Device

STERRAD® SEALSURE® Chemical Indicator Tape cleared under 510(k) K111519 on October 3, 2012.

13

Device Description

The STERRAD™ SEALSURE™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD™ Sterilization Systems that utilize hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices.

The Chemical Indicator Tape reacts with hydrogen peroxide as it is introduced into the sterilization chamber. The chemical reaction between the indicator ink and the hydrogen peroxide causes the dye of the indicator ink on the diagonal STERRAD logos and the chemical indicator square on the tape to change color, indicating that the load has been exposed to hydrogen peroxide.

STERRAD SEALSURE Chemical Indicator Tape does not imply that sterilization has been achieved or to assure that the sterilization cycle has been completed.

Intended Use/Indications For Use

STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:

STERRAD™ 100S .
STERRAD NX™ .
- STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
. STERRAD™ 100NX
- STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
- ം

The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.

| Device

Characteristics	Subject Device	Predicate Device
	STERRAD™ SEALSURE™ Chemical
Indicator (CI) Tape (K234084)	STERRAD® SEALSURE® Chemical
Indicator Tape (K111519)
Intended Use	STERRAD SEALSURE Chemical
Indicator (CI) Tape is a process
indicator intended for use by
healthcare providers to secure non-
woven sterilization packs and wraps to
be sterilized in the STERRAD
Sterilization Systems.	Same

Comparison of Technological Characteristics

14

| Device

Characteristics	Subject Device	Predicate Device
Indications for
Use	STERRAD™ SEALSURE™ Chemical
Indicator (CI) Tape (K234084)

STERRAD™ SEALSURE™ Chemical
Indicator Tape is a process indicator
(ISO 11140-1:2014 [Type 1]) intended
for use by health care providers to
secure non-woven sterilization packs
and wraps to be sterilized in the
STERRAD™ Sterilization Systems:
STERRAD™ 100S STERRAD NX™ STANDARD AND
ADVANCED Cycles with
and without ALLClear™
Technology STERRAD™ 100NX STANDARD, FLEX,
EXPRESS, and DUO
Cycles with and
without ALLClear™
Technology ULTRA GI™ Cycle with
Integrated ALLClear™
Technology The color of the STERRAD SEALSURE
Chemical Indicator Tape changes
from red to gold (or lighter) indicated
by comparator bar when exposed to
hydrogen peroxide and is intended to
differentiate between processed and
unprocessed loads. | STERRAD® SEALSURE® Chemical
Indicator Tape (K111519)

STERRAD® SEALSURE® Chemical
Indicator Tape (PN 14202) is a process
indicator (ISO 11140-1:2005) intended
for use by healthcare providers to
secure non-woven sterilization packs
and wraps to be sterilized in the
STERRAD® Sterilization Systems.
MODELCYCLE STERRAD®
100SStandard STERRAD®
50Standard STERRAD®
200Standard STERRAD®
NXStandard
Advanced STERRAD®
100NXStandard
Flex
Express
DUO The color of the STERRAD® SEALSURE®
Chemical Indicator Tape changes from
red to gold (or lighter) when exposed
to hydrogen peroxide and is intended
to differentiate between processed and
unprocessed loads. | | | | | | | | | | | | |
| Precaution | None | This product contains dry natural
rubber. | | | | | | | | | | | | |
| Type of Chemical
Indicator | Through-put process indicator | Same | | | | | | | | | | | | |

15

Device	Subject Device	Predicate Device
Characteristics	STERRAD™ SEALSURE™ Chemical
Indicator (CI) Tape (K234084)	STERRAD® SEALSURE® Chemical
Indicator Tape (K111519)
Chemical
Reaction	Oxidation-reduction reaction
specifically designed to react in the
presence of hydrogen peroxide. The
reaction is not reversible.	Same
Packaging	Six individually wrapped rolls per
shipper box.	Same
Design	STERRAD System logo / CI square
changes from red to gold (or lighter)
upon exposure to the sterilant,
hydrogen peroxide.	Same
Distinct Color
Change	Red (pre-processed) to gold or lighter
(post-processed)	Same
Single Use Device	Yes	Same

Summary of Non-Clinical Testing

Performance Testing	Description	Acceptance Criteria	Pass/Fail
Chemical Indicator
Functionality	This study verified the
Chemical Indicator
functionality after
processing in the ULTRA
GI Cycle.	The Chemical Indicator
will not change color
when not exposed to
the cycle parameter
indication.
The Chemical Indicator
will change color when
exposed to cycle
parameter indication.	Pass
Residual
Biocompatibility	This study
demonstrated the
biocompatibility of the
Chemical Indicator post
processing in the ULTRA
GI Cycle.	The residual hydrogen
peroxide level shall be
below the LOQ and
exhibit mild toxicity or
lower.	Pass
End Point /Post
Processing Color
Stability	This study
demonstrated that the
Chemical Indicator
perform to the Type 1	The chemical indicator
shall perform to the
Type 1 requirements of
ISO 11140-1:2014.	Pass

16

| | requirements of ISO
11140-1:2014. | | |
|------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------|
| | | | |
| Tape Adhesion Strength | This study verifies the
adhesive strength after
processing in the ULTRA
GI Cycle. | The peel strength
(adhesion-strength)
must meet the
acceptance criteria. | Pass |

Summary

The subject device, STERRAD SEALSURE Chemical Indicator (Cl) Tape (14202NL), and its predicate utilize the same technology and verification/validation methods to achieve the intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject device to be as safe and effective as the predicate.

Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the existing legally marketed predicate device, K111519.

17

510(k) Summary for K234084 Advanced Sterilization Products, Inc. STERRAD VELOCITY™ Biological Indicator (BI) and STERRAD VELOCITY™ Reader

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information
Submitter Name:	Advanced Sterilization Products, Inc.
Address:	33 Technology Drive
Irvine, CA 92618
Contact Person:	Brandon Roberts
Senior Regulatory Affairs Specialist
Phone: (323) 590-4214
Email: brandon.roberts@asp.com
Date Prepared:	July 2, 2024
Device Name
Proprietary Name:	STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count), STERRAD
VELOCITY™ Biological Indicator (BI) (43210-30) (30 count) and STERRAD
VELOCITY™ Reader (43220)
Common Name:	Biological Indicator
Classification Name:	Indicator, Biological Sterilization Process
Device Class:	Class II
Product Code:	FRC
CFR Section:	21 CFR 880.2800

Predicate Device

STERRAD VELOCITY® Biological Indicator/Process Challenge Device (BI/PCD) and STERRAD VELOCITY® Reader cleared under 510(k) K192025 on January 23, 2020.

18

Device Description

The STERRAD VELOCITY Biological Indicator (BI) is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and/or periodic testing in STERRAD Sterilization Systems.

Intended Use/Indications For Use

The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:

. STERRAD™ 100NX Sterilization System
- STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
- ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only). o
. STERRAD NX™ Sterilization System
- (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
. STERRAD™ 100S Sterilization System

| Device

Characteristics	Subject Device	Predicate Device
Intended Use	STERRAD VELOCITY™ BI and STERRAD
VELOCITY™ Reader (K234084)	STERRAD VELOCITY™ BI/PCD and
Reader (K192025)
	Monitoring of hydrogen peroxide gas
plasma sterilization processes.	Same
Indications for Use	The STERRAD VELOCITY™ Biological
Indicator (BI)/Process Challenge Device
(PCD), in conjunction with the STERRAD
VELOCITY™ Reader, is intended to be
used as a standard method for frequent
monitoring and/or periodic testing of
the following STERRAD™ Systems:
• STERRAD™ 100NX Sterilization
System
• STANDARD, FLEX,
EXPRESS, and DUO
Cycles with and without
ALLClear™ Technology
• ULTRA GI™ Cycle with
Integrated ALLClear
Technology (for	STERRAD VELOCITY® Biological
Indicator/Process Challenge Device, in
conjunction with the STERRAD VELOCITY
Reader, is intended to be used as a
standard method for frequent
monitoring and periodic testing of the
following STERRAD Sterilization Systems:
• STERRAD® IOONX (STANDARD,
FLEX, EXPRESS, and DUO
Cycles) with and without
ALLClear® Technology
• STERRAD NX® (STANDARD and
ADVANCED Cycles) with and
without ALLClear® Technology
• STERRAD 100S
	Subject Device	Predicate Device
Device
Characteristics	STERRAD VELOCITY™ BI and STERRAD
VELOCITY™ Reader (K234084)
frequent monitoring
only).
• STERRAD NX™ Sterilization
System
o (STANDARD AND
ADVANCED Cycles) with
and without ALLClear™
Technology
• STERRAD™ 100S Sterilization
System	STERRAD VELOCITY™ BI/PCD and
Reader (K192025)
Organism
(Spore, Species,
Strain)	Geobacillus stearothermophilus
ATCC 7953	Same
Viable Spore
Population	$\ge$ 1x106 CFU/BI	Same
Carrier Material	Glass Fiber	Same
Device Design	Self-contained biological indicator.	Same
Resistance
Characteristics	• Tested at 5 mg/L hydrogen peroxide:
D-value 5mg/L: $\ge$ 1 second, using two
D-value methods (Survivor Curve and
Fraction Negative) per ISO 11138-1.
• Equal to or greater than the most
difficult item routinely processed
(biological model).	Same
Rapid Readout
Technology	The α-glucosidase enzyme system is
generated naturally during the growth
of Geobacillus stearothermophilus. The
α-glucosidase enzyme in its active state
is detected by measuring the
fluorescence produced by the enzymatic
hydrolysis of a non-fluorescent
substrate. The resultant fluorescent by-
product is detected in the reader. The
fluorescence signal is used to determine
a positive or negative result.	Same
Incubation
Temperature	57 +/- 2°C	Same
Incubation Time	15-minute fluorescence results read in	Same
	Subject Device	Predicate Device
Device
Characteristics	STERRAD VELOCITY™ BI and STERRAD
VELOCITY™ Reader (K234084)	STERRAD VELOCITY™ BI/PCD and
Reader (K192025)
	visual pH color change results at 5 to 7
days.
Holding Time	Within 2 hours after sterilization cycle	Same
Carrier growth
inhibition/media
growth promotion	No bacteriostatic effects that inhibit the
growth of the indicator microorganism	Same
Chemical Indicator	Type 1 process indicator changes color
from red/pink to yellow or yellow with
some red/orange/brown dots to
indicate exposure to hydrogen peroxide.	Same
Method of
Fluorescence
Detection	UV LED, optical filters, with sensing by
photodiode	Same
Indicator of
Adequate
Sterilization Cycle	"Negative" displayed on LCD Display	Same
Indicators of
Possible Sterilization
Cycle Failure	"Positive" displayed on LCD Display,
Audible Alarm	Same
Incubation Wells	8 incubation/reader wells	Same
Voltage Range	100-240 Volts AC (12 Volt DC conversion
for internal circuitry)	Same
Product Safety	UL/IEC 61010-1	Same
EMC Compliance	FCC Part 15, Subpart B, Class A	Same

Comparison of Technological Characteristics

19

20

Summary of Non-Clinical Testing -Device

Performance Testing	Description	Acceptance Criteria	Pass/Fail
Biological Indicator
Performance	This study verified the
use of the Biological
Indicator for use in
frequent monitoring of
the ULTRA GI Cycle.	General trend of
increasing number of
sterile Bls (growth and
fluorescence) with
increasing hydrogen
peroxide injection
volume. All Bls negative
for fluorescence and
growth at full cycle.	Pass

21

| Verification of Growth
Inhibition of the
Biological Indicator | The study demonstrated
that there is no
inhibition effect on the
STERRAD VELOCITY BI
carrier and primary
packaging materials
processed through the
ULTRA GI Cycle. | All test samples (positive
controls) show growth.
All negative controls
show no growth. | Pass |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Chemical Indicator
Functionality of
Biological Indicator | This study verified the
Chemical Indicator
functionality after
processing in the ULTRA
GI Cycle. | Chemical Indicator will
not change color when
not exposed to the cycle
parameter indication.
Chemical Indicator will
change color when
exposed to cycle
parameter indication. | Pass |
| Fluorescence
Performance of
Biological Indicator | This study verified the
accuracy of the
Fluorescence results
compared to growth
positive Bls. | BI fluorescence-positive
for greater than 97.0%
of all growth-positive
Bls. | Pass |

Summary

The subject devices STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count), STERRAD VELOCITY™ Biological Indicator (BI) (43210-30) (30 count) and STERRAD VELOCITY™ Reader (43220), as well as their predicate, utilize the same technology and verification methods to achieve the intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject devices to be as safe and effective as the predicate.

Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the existing legally marketed predicate device, K192025.

22

510(k) Summary for K234084 Advanced Sterilization Products, Inc. ULTRA GI™ Process Challenge Device (PCD) Vial

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information

Submitter Name:	Advanced Sterilization Products, Inc.
Address:	33 Technology Drive
Irvine, CA 92618
Contact Person:	Brandon Roberts
Senior Regulatory Affairs Specialist
Phone: (323) 590-4214
Email: brandon.roberts@asp.com
Date Prepared:	July 2, 2024
Device Name
Proprietary Name:	ULTRA GI™ Process Challenge Device (PCD)
(43400) (30 count)
Common Name:	Process Challenge Device
Classification Name:	Indicator, Biological Sterilization Process
Device Class:	Class II
Product Code:	FRC
CFR Section:	21 CFR 880.2800

Predicate Device

STERRAD VELOCITY® Biological Indicator/Process Challenge Device and STERRAD VELOCITY® Reader cleared under 510(k) K192025 on January 23, 2020.

23

Device Description

The assembled ULTRA GI PCD is composed of a vial that encapsulates the STERRAD VELOCITY Biological Indicator (BI). The vial creates a stronger resistance to the ULTRA GI Cycle. At the end of the Bl is removed from the vial and used in conjunction with the STERRAD VELOCITY Reader (software version 1139260417 or newer) to verify the effectiveness of the ULTRA GI PCD Vial is only used for the ULTRA GI Cycle in STERRAD 100NX Sterilizers.

Intended Use/Indications For Use

The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (BI) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ 100NX Sterilization System with ALLClear™ Technology.

	Subject Device	Predicate Device
Device
Characteristics	ULTRA GI™ PROCESS CHALLENGE
DEVICE (PCD) Vial (K234084)	STERRAD VELOCITY™ BI/PCD and
Reader (K192025)
Intended Use	Monitoring of hydrogen peroxide gas
plasma sterilization processes when
used in conjunction with the STERRAD
VELOCITY™ BI.	Same
Indications for Use	The ULTRA GI™ Process Challenge
Device (PCD) Vial is used with the
STERRAD VELOCITY™ Biological
Indicator (BI) for periodic testing and
frequent monitoring of the ULTRA GI™
Cycle in the STERRAD™ 100NX
Sterilization System with ALLClear™
Technology.	STERRAD VELOCITY® Biological
Indicator/Process Challenge Device, in
conjunction with the STERRAD VELOCITY
Reader, is intended to be used as a
standard method for frequent
monitoring and periodic testing of the
following STERRAD Sterilization Systems:
STERRAD® 100NX (STANDARD,
FLEX, EXPRESS, and DUO
Cycles) with and without
ALLClear® Technology STERRAD NX® (STANDARD and
ADVANCED Cycles) with and
without ALLClear® Technology STERRAD 100S
Vial Material	Polypropylene (vial)
Buna-N (O-rings in vial)
Polyester+acrylic adhesive (label)	N/A
Device Design	ULTRA GI™ Process Challenge Device
(PCD) Vial encapsulates the STERRAD
VELOCITY™ Biological Indicator (BI).	Self-contained biological indicator.

Comparison of Technological Characteristics

24

| Device

Characteristics	Subject Device	Predicate Device
Resistance
Characteristics	ULTRA GI™ PROCESS CHALLENGE
DEVICE (PCD) Vial (K234084)	STERRAD VELOCITY™ BI/PCD and
Reader (K192025)
	Tested at 5 mg/L hydrogen peroxide:
D-value $_{5mg/L}$ : ≥ 1 second, using two
D-value methods (Survivor Curve and
Fraction Negative) per ISO 11138-1. Equal to or greater than the most
difficult item routinely processed
(biological model).	Same

Summary of Non-Clinical Testing - Biological Indicator/Process Challenge Device

Performance Testing	Description	Acceptance Criteria	Pass/Fail
Hydrogen Peroxide
Dose-Response and
Sterilization Verification	This study verified the
design of the ULTRA GI
PCD fluorescence. The BI
readout in conjunction
with the PCD vial
provides a greater
resistance in
comparison to the
biological model to the
sterilization process
using the ULTRA GI
Cycle.	The general trend is an
increasing number of
sterile Bls (growth and
fluorescence) with
increasing hydrogen
peroxide injection
volume. All BIs are
negative for
fluorescence and growth
at full cycle.	Pass
Performance
Qualification	This study verified the
fluorescence read
performance when used
for period testing and
frequent monitoring.	The STERRAD VELOCITY
BI/PCD fluorescence
readout is qualified for
performance in frequent
monitoring and periodic
testing indication.	Pass

25

Summary

The subject device, ULTRA GI Process Challenge Device (PCD) Vial (43400) (30 count), and its predicate utilize the same technology and verification/validation methods to achieve the intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject devices to be as safe and effective as the predicate.

Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the existing legally marketed predicate device, K192025.